Vascular Endothelial Function and Cardiac Resynchronization Response in Patients With Heart Failure

Mayo Clinic

Status: Terminated

Conditions: Heart Failure

Treatments: Diagnostic Test: Peripheral arterial tonometry (PAT); Procedure: Subcutaneous adipose tissue collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02783716

15-006402

Details and patient eligibility

About

The purpose of this research study is to determine the role of blood vessel endothelial function in heart failure and the effect of Cardiac Resynchronization Therapy (CRT) on heart and endothelial function.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CRT Group: Patients recommended for CRT-P or CRT-D for heart failure (HF) according to current American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) guidelines of Left Ventricle Ejection Fraction (LVEF)<35%, Left Bundle Branch Block (LBBB)>120 ms, New York Heart Association (NYHA) Class II-III).
• Control Group: Patients who undergo device (pacemaker or ICD) implantation or a pack change for sinus node dysfunction or AV blocks

Exclusion criteria

• Patients who are unwilling or unable to return for follow up visits 3 months after device implantation.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Cardiac Resynchronization Therapy (CRT) Group

Active Comparator group

Description:

Participants undergoing Cardiac Resynchronization Therapy Implantation (CRT) implantation for heart failure as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue

Treatment:

Diagnostic Test: Peripheral arterial tonometry (PAT)

Procedure: Subcutaneous adipose tissue collection

Control Group

Active Comparator group

Description:

Participants undergoing device pacemaker or implantable cardioverter-defibrillator (ICD) implantation or pack change for sinus node dysfunction or Atrioventricular (AV) block as part of standard of care will receive EndoPAT testing and collection of subcutaneous adipose tissue

Treatment:

Diagnostic Test: Peripheral arterial tonometry (PAT)

Procedure: Subcutaneous adipose tissue collection